In brief, we bring in our products in bulk and repack them (exposed) into our various sizes. There is no further 'processing' just repacking.

We put the best by date of manufacture (co-manufacturer's date) on the package as well as a Julian date lot code so we know what day it ran in house. We do NOT track in our system to the customer, however, the LOT. We only track the best by date printed.

So far the reasoning behind this is that if we had a recall, it would be because of something within the product and would need to flow back to the manufacturer. The risk of any sort of legitimate recall coming from in-house production (based on the LOT) is slim to none.

So what I can't figure out is for our small business operation, what is necessary in order to be compliant? Do we need to be able to trace our day of repacking downstream?

In the event that there's a recall, we would recall by best by date anyways in which case we would be acting as over-precautious.

In my experience in the cheese repacking world, the BBD is all we used. We were a level 3 SQF facility and never had any auditor question that procedure. The way it was set up was that if a consumer called and had the BBD we could in turn track it back to the lot/supplier it came from.

There's always room for improvement. Repackaging does not absolute your company of all liability, risk and hazards. Let me ask you this, is your process truly risk and hazard free? Do any our your candies contain allergens? What happen if a non allergen candy is cross contaminated with something like peanuts. How to you initiate a recall? Which customers received the contaminated products?

In my experience in the cheese repacking world, the BBD is all we used. We were a level 3 SQF facility and never had any auditor question that procedure. The way it was set up was that if a consumer called and had the BBD we could in turn track it back to the lot/supplier it came from.

Interesting, not what I expected to hear especially from someone packaging something more susceptible to contamination (mold, etc) that you wouldn't have to track your packaging.

There's always room for improvement. Repackaging does not absolute your company of all liability, risk and hazards. Let me ask you this, is your process truly risk and hazard free? Do any our your candies contain allergens? What happen if a non allergen candy is cross contaminated with something like peanuts. How to you initiate a recall? Which customers received the contaminated products?

I would reevaluate your process and HACCP plans.

We are organic, Kosher, vegan or vetearian, and free of the top 8 allergens within our whole company actually. We don't even allow people to bring peanuts in their lunches. So I think that's where the risk has been deemed so low.

Of course as Dir of Ops I want to be over conscious of 'what if' considering intentional contamination, unlikely contamination, and things that realistically, won't happen.

We put the best by date of manufacture (co-manufacturer's date) on the package as well as a Julian date lot code so we know what day it ran in house. We do NOT track in our system to the customer, however, the LOT. We only track the best by date printed.

So far the reasoning behind this is that if we had a recall, it would be because of something within the product and would need to flow back to the manufacturer. The risk of any sort of legitimate recall coming from in-house production (based on the LOT) is slim to none.

Regret no idea about FSMA but, as you mentioned, the traceability requirement ultimately comes down to the necessity of quantifying the history associated with any product subsequently involved in a recall.

Horsemeat is the currently topical European example of course, albeit not a specific safety issue. Sort of repacking.

We are a repacker also and pertaining to traceability, I would strongly urge you to research the tomato pathogen outbreak in the US in 2008. For some time no farm or repacker could even move a tomato, more so from Florida and Mexico. Most crops or holdings were dumped. The reason was what you describe, all product was dumped together (commingled) with out benefit of tracking lot numbers from the suppliers. Once the FDA saw what a mess this was they basically shut the entire operation down. No one could tell where any of there tomatoes truly canme from. The cruel irony of this story is that about 6 months later it was determined that the outbreak had been caused by peppers. Granted, that incident was caused by industry wide practices. If you do not improve your system of tracking your risk seems to remain extremely large and unmanageble in the event of a recall or even investigation. I also suggest you rethink your position on the original supplier being the sole responsibility for any problems. If the product is in your facility it is guaranteed to also be your problem.

Labeling requirements from customers including GS1 implementation are decreasing these risks at the same time they make production more complex.

Bottom line: More effort and documentation for traceability equals smaller scope of risk. I dont believe the it is a question of if you will ever have a recall, the question is when and whether you are prepared for it.

We are a repacker also and pertaining to traceability, I would strongly urge you to research the tomato pathogen outbreak in the US in 2008. For some time no farm or repacker could even move a tomato, more so from Florida and Mexico. Most crops or holdings were dumped. The reason was what you describe, all product was dumped together (commingled) with out benefit of tracking lot numbers from the suppliers. Once the FDA saw what a mess this was they basically shut the entire operation down. No one could tell where any of there tomatoes truly canme from. The cruel irony of this story is that about 6 months later it was determined that the outbreak had been caused by peppers. Granted, that incident was caused by industry wide practices. If you do not improve your system of tracking your risk seems to remain extremely large and unmanageble in the event of a recall or even investigation. I also suggest you rethink your position on the original supplier being the sole responsibility for any problems. If the product is in your facility it is guaranteed to also be your problem.

Labeling requirements from customers including GS1 implementation are decreasing these risks at the same time they make production more complex.

Bottom line: More effort and documentation for traceability equals smaller scope of risk. I dont believe the it is a question of if you will ever have a recall, the question is when and whether you are prepared for it.

My only extended comment in response to this - because I think you make valid points - is that we are not 'mixing' lot codes or product from manufacturers. We simply run it through a line to package.

I feel like you say a lot of what I think and know but I'm just working to get hard evidence that this is something we should implement now and not wait until we are forced to and larger. I understand narrowing the scope of a recall and not assuming we are 'no risk' of internal contamination. Seems that we plan to be over-cautious in recalling a total Best By date (which refers to the lot of the co-man) so I'm trying to build a case as to why we should also track our day of packaging.

Good to hear that you are already on board with what i had to say. The truth is, a lot of companies choose to keep the increased risk due to cost factors and the actual probability of somthing happening which would require a recall.

One last thought, if you increase your effort and accountability now and consistently manage it during growth it will be much simpler to keep the program implemented and upgrade it.

A few additional thoughts on this, do you know how your suppliers (you use the term co-manufacturer, but aren't they really suppliers) trace their product? Do they ever pack multiple lots with the same best by date?

The key to defend a traceability/recall program is to be able to quickly (2 hours or so) identify all the pounds that have been indicated as a potential problem and where they went. If you can show not only that you can capture the problem but also proof that you reconcile the pounds against what was shipped to you then you have a good program. You do not mention any history of recall exercises and the ability to reconcile pounds; has that been done and what sort of % reconciliation was able to be achieved?

As for the rationale that states slim to no chance of a bad outcome due to in house failures; do you clean and maintain your equipment, have people working the lines, perhaps handling the food, do you have forklifts with the potential to leak lubricants, do you have allergens of different types on your lines, do you pack into purchased food contact materials? All of these activities have risk that could potentially trigger a recall based on your Julian date, but to me that would probably be easier to trace than a supplier initiated recall with your current system.

I worked for a number of years with pistachios were a lot of pre-packaging mixing occurs and that was a traceability nightmare to get back to the grower, this does not sound that bad and very doable.

A few additional thoughts on this, do you know how your suppliers (you use the term co-manufacturer, but aren't they really suppliers) trace their product? Do they ever pack multiple lots with the same best by date?

The key to defend a traceability/recall program is to be able to quickly (2 hours or so) identify all the pounds that have been indicated as a potential problem and where they went. If you can show not only that you can capture the problem but also proof that you reconcile the pounds against what was shipped to you then you have a good program. You do not mention any history of recall exercises and the ability to reconcile pounds; has that been done and what sort of % reconciliation was able to be achieved?

As for the rationale that states slim to no chance of a bad outcome due to in house failures; do you clean and maintain your equipment, have people working the lines, perhaps handling the food, do you have forklifts with the potential to leak lubricants, do you have allergens of different types on your lines, do you pack into purchased food contact materials? All of these activities have risk that could potentially trigger a recall based on your Julian date, but to me that would probably be easier to trace than a supplier initiated recall with your current system.

I worked for a number of years with pistachios were a lot of pre-packaging mixing occurs and that was a traceability nightmare to get back to the grower, this does not sound that bad and very doable.

I like some of where you're going here.

As I mentioned to someone else earlier, we are allergen free (its one of our claims and part of our niche). I think if allergens were an issue we'd be already doing this as a no brainer. But some of the other things you mentioned too. I like seeing this from others because being in Ops and Production, I think this way as well. I'm just struggling with coming up with a convincing argument that get's others on board. They agree to implement if I say so, which makes more work all around, but I don't feel that they understand the strength of reasoning as they feel our vulnerability is low. We do only have one line that runs as well, maybe I should have mentioned that.

Traceability up stream is easy. We have a best by date, which is also printed on the pouch we package that we can trace from consumer upward through our manufacturers. One of the manufacturers Lot codes may have multiple dates but one date will not have multiple lots. (this lot code differs from the one I was previously mentioning that is our Julian date on the pouches).

Again, appreciating this discussion as I am taking bits and pieces into mind as I go forth and continue conversations with my counterparts.